MAUDE Adverse Event Report: DEXCOM INC DEXCOM G6; SENSOR, GLUCOSE, INVASIVE

Model Number DEXCOM G6 SENSOR

Device Problem Fluid/Blood Leak (1250)

Patient Problems Itching Sensation (1943); Contact Dermatitis (4546)

Event Date 11/10/2020

Event Type  Injury  

Event Description

I have severe contact dermatitis from the adhesive used for my dexcom g6.This started about 30 days ago and is just progressing to worse.My current sensor is overly itchy and is leaking an orangish fluid from wearing the device.I haven't changed anything so it must be something dexcom is using on this batch of sensors.Fda safety report id # (b)(4).

• Brand Name: DEXCOM G6
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM INC
• MDR Report Key: 10837023
• MDR Text Key: 216407215
• Report Number: MW5097852
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DEXCOM G6 SENSOR
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 43 YR
• Patient Weight: 84